Job Description
BASIC FUNCTIONS:
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials and Essential Documents (ED) during the start-up period of the study. Work with internal team to assure good communication, regarding start-up activity. Assure documents during regulatory review for start-up of a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP) and country specific procedures set forth by IQVIA Biotech and its clients. Complete debarment checks for principal and sub investigators as per scope of work.
Role and Responsibilities:
- Serves as final regulatory signature on Essential Regulatory Document Checklist (ERDC) however, cannot be first and final signatory.
- Adheres to study timelines, documents/escalates study challenges and communicates updates to SSU Manager and/or SSU Lead and/or Line/Study Management.
- Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) .
- Support and mentor junior members of staff in the start-up processes.
- Complete debarment checks for principal investigators and sub investigators, as directed.
- May assist with compiling regulatory documents into a complete green light package (GLP), performing a first review prior to submission for final sign-off.
- Perform GLP review and sign off Essential Regulatory Document Checklist [ERDC].
- May assist in creating an ERDC to be reviewed and approved by Regulatory.
- May support SSU Teams in pulling metrics for study teams and Department Leadership.
- Other duties as assigned by line manager.
KNOWLEDGE, SKILLS & ABILITIES:
- Serves as final regulatory signature on Essential Regulatory Document Checklist (ERDC) however, cannot be first and final signatory.
- Adheres to study timelines, documents/escalates study challenges and communicates updates to SSU Manager and/or SSU Lead and/or Line/Study Management.
- Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) .
- Support and mentor junior members of staff in the start-up processes.
- Complete debarment checks for principal investigators and sub investigators, as directed.
- May assist with compiling regulatory documents into a complete green light package (GLP), performing a first review prior to submission for final sign-off.
- Perform GLP review and sign off Essential Regulatory Document Checklist [ERDC].
- May assist in creating an ERDC to be reviewed and approved by Regulatory.
- May support SSU Teams in pulling metrics for study teams and Department Leadership.
- Other duties as assigned by line manager.
- Proficient with regulatory documents, organization and the methods of filing and tracking.
- Strong interpersonal skills with the ability to communicate effectively, both oral and written. Ability to manage multiple competing priorities within various clinical trials.
- Ability to work independently and within a matrix team environment is essential.
- Working knowledge of current ICH GCP guidelines and applicable regulations
- Working knowledge of Word and Excel is required.
- 2 years of relevant clinical research experience
- Equivalent combination of education, training and experience